immunogenicity of the inactivated split-virion influenza vaccine in renal transplant subjects

Conditions: Influenza; Orthomyxoviridae Infections

Summary: primary objective: to describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the im reference vaccine (vaxigrip®). secondary objective: to describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the im reference vaccine

the trial is a multicenter, randomized, controlled trial in renal transplant subjects aged 18 to 60 years who are non-responders to vaccination with the reference vaccine. subjects will be randomized to receive either the 2007-2008 15 µg investigational vaccine or the 2007-2008 im reference vaccine.

Eligibility criteria:
inclusion criteria: * able to attend all scheduled visits and to comply with all trial procedures. * subject with renal transplant for at least 6 months. * subject with stable renal function, i.e. with a variation of creatinin value \ 20 ml/min during the 3 months preceding inclusion. * aged 18 to 59 years on the day of the screening visit. * informed consent form signed. * subject entitled to national social security. * subject under immunosuppressive therapy. * for a woman, inability to bear a child or negative urine pregnancy test. * subject non-responder to previous im vaccination with the 2006-2007 northern hemisphere vaxigrip® formulation. exclusion criteria: * subject with sign of transplanted kidney reject within 3 months preceding vaccination according to medical practice. * systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. * febrile illness (oral temperature ≥ 37.5°c, or rectal equivalent temperature ≥ 38.0°c) on the day of inclusion. * breast-feeding. * participation in another clinical trial in the 4 weeks preceding the trial vaccination. * planned participation in another clinical trial during the present trial period. * congenital immunodeficiency, anti-cancer chemotherapy or radiation therapy within the preceding 6 months. * chronic illness, except renal failure or renal disorders, at a stage that could interfere with trial conduct or completion. * current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures. * blood or blood-derived products received in the past 3 months . * any vaccination in the 4 weeks preceding the trial vaccination. * vaccination planned in the 4 weeks following the trial vaccination. * thrombocytopenia or bleeding disorder contraindicating intramuscular (im) vaccination * previous vaccination against influenza in the preceding 6 months. * subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Keywords: influenza orthomyxoviridae infections renal transplant